Psychological Interventions to Prevent Late Effects in Breast Cancer

Breast Cancer Clinical Trial

— PREVENT  

Official title:

Pre- and Post-operative Psychological Interventions to Prevent Pain and Fatigue After Breast Cancer Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518085
• Other study ID #: 201906
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: December 2023
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to investigate whether a combined pre-operative medical hypnosis plus a post-operative internet-based acceptance and commitment intervention are more effective in preventing post-surgical pain and fatigue following breast cancer surgery compared with pre-operative mindfulness plus treatment as usual.

Description:

The trial will include 200 patients undergoing breast cancer surgery at Oslo University Hospital. The patients will be randomized into two groups. One group will receive a 20 minute pre-surgical hypnosis session delivered by an experienced clinical psychologist plus a post-surgical internet-based acceptance and commitment intervention. The control group will receive a 20 minute pre-surgical mindfulness session delivered through an audio recording plus treatment as usual. The primary outcomes of the study are quantitative measures of post-surgical pain and fatigue. In addition, relationships between biomarkers of stress and subacute post-surgical pain and fatigue will be analyzed using using blood- and hair samples. The study uses a longitudinal design with baseline measures obtained pre-surgery and follow up measures obtained 3 and 12 months post-surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: November 1, 2023
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Women diagnosed with breast cancer and scheduled for surgery
• Be able to provide informed consent

Exclusion Criteria:

• Insufficient Norwegian speaking or writing skills to participate in the interventions and fill out questionnaires
• Cognitive and psychiatric impairment
• Other serious malignancies

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue
• Pain, Postoperative

Intervention

Behavioral:
• Medical hypnosis
Single session 20 minutes hypnosis session originally developed and tested by Montgomery et al. (2007) in a similar setting. Delivered by an experienced clinical psychologist.
• Internet-based Acceptance and Commitment Therapy (iACT)
Access to an online platform developed to this study containing video clips and audio files with ACT consistent material
• Mindfulness session
Single session mindfulness session delivered by audio file
• Treatment as Usual (TAU)
Treatment as usual as part of post-surical care

Locations

Country	Name	City	State
Norway	Oslo University Hospital (Aker Hospital)	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (4)

Engel S, Jacobsen HB, Reme SE. A cross-sectional study of fear of surgery in female breast cancer patients: Prevalence, severity, and sources, as well as relevant differences among patients experiencing high, moderate, and low fear of surgery. PLoS One. 2023 Jun 23;18(6):e0287641. doi: 10.1371/journal.pone.0287641. eCollection 2023. — View Citation

Lind SB, Jacobsen HB, Solbakken OA, Reme SE. Clinical Hypnosis in Medical Care: A Mixed-Method Feasibility Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211058678. doi: 10.1177/15347354211058678. — View Citation

Munk A, Jacobsen HB, Schnur J, Montgomery G, Reme SE. Acute and subacute postsurgical pain in women with breast cancer: incidence and associations with biopsychosocial predictors-a secondary analysis of a randomized controlled trial. Pain Rep. 2023 Jan 10;8(1):e1058. doi: 10.1097/PR9.0000000000001058. eCollection 2023 Jan. — View Citation

Reme SE, Munk A, Holter MTS, Falk RS, Jacobsen HB. Pre- and post-operative psychological interventions to prevent pain and fatigue after breast cancer surgery (PREVENT): Protocol for a randomized controlled trial. PLoS One. 2022 Jul 8;17(7):e0268606. doi: 10.1371/journal.pone.0268606. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic post-surgical pain	Measured through a Numeric Rating Scale (NRS) for pain intensity. The scale ranges from 0-10, anchored by verbal descriptors at either end of the scale where 0 is no pain at all and 10 is the worst possible pain.	3 months after surgery
Primary	Post-surgical fatigue	Measured through the 13-item Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F) which is a unidimensional self-report scale to assess fatigue and its impact on daily life. The score range is 0-52 where a higher score indicates better quality of life (i.e. less symptoms and disability)	3 months after surgery
Secondary	Pain intensity, pain unpleasantness, fatigue, nausea, physical discomfort and emotional upset	Measured by a Visual Analogue Scale (VAS) (to replicate a previous hypnosis trial - Montgomery et al 2007). The range is 0-100 where a higher score indicates more intense symptoms.	On the day of surgery right before discharge
Secondary	Stress (immunological) reactivity	Immune function is assessed through whole blood samples using the standardized TruCulture system that contains immunogenic stimuli (infected tubes). This test will reveal the induced innate and adaptive immune response in whole blood after stimulation with LPS, by quantifying the release of soluble immune activation products (cytokines, chemokines, soluble receptors etc.) in the supernatant and by measuring the transcription level (mRNA) in the circulating blood (immune) cells.	Baseline (pre-surgery) plus 4 weeks post-surgery (Cortisol will only be measured at baseline)
Secondary	Number of psychotropic and pain-related prescriptions	Usage of psychotropic and pain medication obtained through registry data from the Norwegian Prescription Database at 3 and 12 months follow-up. Number of prescriptions will be summarized and compared between intervention and control group.	3 and 12 months post-surgery
Secondary	Number of sick leave days	Days away from work on sick leave will be measured through registry data	3 and 12 months post-surgery
Secondary	Psychological flexibility	Measured through the Acceptance and Action Questionnaire (AAQ-II). The scale ranges from 7-49, where higher score indicates more psychological inflexibility	3 and 12 months post-surgery
Secondary	Psychological distress	Measured through the Hospital Anxiety and Depression Scale (HADS). The total score ranges from 0-42, where a higher score indicates more symptoms	3 and 12 months post-surgery

External Links

•   Project web page